REVIEWS

DMC Services

Data Monitoring Committee (DMC)

Navigate complex regulatory landscapes, make data-informed decisions, and ensure robust oversight with flexible DMC services from the fastest DMC administrator.

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Global Expertise and Flexibility Combined

No matter the therapeutic area, study design, geographic region, or other unique study considerations — our experienced team and flexible processes can scale to support any project. We work with you to determine the right membership for your data monitoring committee while operating independently to eliminate any appearance of conflict.

Unmatched Expertise

Advarra has the largest worldwide expert network of any DMC provider. Our expansive network of 1,500+ biostatisticians, medical experts, biostatisticians, and other clinical professionals provide deep expertise in all therapeutic areas, trial designs, and complex biostatistical endpoints.

Improved Independence

DMCs must be independent from the sponsor per U.S. FDA and EU EMA guidelines. Separate clinical trial oversight from trial execution and conduct with Advarra’s DMC services. Our DMCs maintain the highest level of independence to safeguard study objectivity and scientific rigor.

Optimized Compliance

Save time and resources with truly integrated review services. While the review committees are separate, Advarra coordinates all the institutional review board (IRB), institutional biosafety committee (IBC), DMC, and endpoint adjudication committee (EAC) reviews to reduce delays and ensure consistency.

Fastest Turnaround Times

No other DMC provider goes faster than Advarra. During the trial, the DMC convenes meetings at the frequency outlined in the charter. After the meeting, Advarra provides the DMC’s recommendations to the sponsor/contract research organization (CRO) within one business day.

Comprehensive DMC Services

Setup and charter

Advarra-administered independent committee formation
Collaborative development of DMC charter and member selection with sponsor/CRO
Recruitment and contracting of qualified biostatistical and disease condition experts
Secure data exchange management through SOAR

Statistical analysis and meetings

Secure data exchange management
Technology platform for safety oversight administration and reporting (SOAR)
Statistical analysis and meetings
Establishment of secure data transfer
Programming of statistical tables, listings, and graphs (TLGs) per the DMC charter
Convene meetings for safety review and interim analysis
Active collaboration with sponsor/CRO on safety issues
Rapid production of DMC recommendations and report to sponsor/CRO
Year-round compliance management
On-demand meeting services

Education and consulting

Sponsor/CRO training on DMC process
Data safety monitoring plan development consulting for clinical protocol
Biostatistical design consulting for efficient endpoints

Statistical analysis and meetings

Develop DMC statistical analysis plans (SAPs)
Create statistical analysis software (SAS)-derived data set programs
Create TLG programs
Serve as unblinded statisticians on DMC
Validation of SAS programming per 21 CFR Part 11 standards
Prepare periodic statistical reports for the DMC per SAP

While Advarra’s DMC Statistical Center typically works with the Advarra-administered DMC, we can also prepare TLGs for DMCs administered by other parties.

Independence is Critical to Regulators

DMCs must be independent from the sponsor per U.S. FDA and EU EMA guidelines. The FDA’s 2024 draft guidance emphasizes the “critical” need for DMC reviews to be truly independent from those sponsoring, organizing, or conducting the trial.

Separate clinical trial oversight from trial execution and conduct with impartiality from Advarra’s DMC services.

Comprehensive DMC Services

Setup and charter

Advarra-administered independent committee formation
Collaborative development of DMC charter and member selection with sponsor or CRO
Recruitment and staffing contracting of qualified biostatistical and disease condition experts

Secure data exchange management

Technology platform for safety oversight administration and reporting (SOAR)
Statistical analysis and meetings
Establishment of secure data transfer
Programming of statistical charts and methods tables, listings, and graphs (TLGs) per the DMC charter
Convene meetings for safety review and interim analysis
Active collaboration with sponsor/CRO on safety or design issues
Rapid production of DMC recommendations and report to sponsor/CRO
Year-round compliance management
On-demand meeting services

Education and consulting

Sponsor/CRO training on DMC process
Data safety monitoring plan development consulting for clinical protocol
Biostatistical design consulting for efficient endpoints

DMC Statistical Center services

Develop DMC SAPs
Create statistical analysis software
Create TLG programs
Serve as unblinded statisticians on DMC

While our DMC Statistical Center typically works with the Advarra administered DMC, we can also prepare TLGs for DMCs administered by other parties.

Independence is Critical to Regulators

Separate clinical trial oversight from trial execution and conduct with impartiality from Advarra’s DMC services.

Featured Content

Info Sheet

Data Monitoring Committee (DMC) Services Info Sheet

Advarra’s biostatistical and medical experts offer customized DMC solutions, aligning oversight with the specific needs of your clinical trial.

Blog

The Importance of Keeping DSMBs Independent

Establishing DSMB independence helps mitigate bias, ensuring clinical trials adhere to regulatory standards and build public trust.

Blog

Understanding FDA’s 2024 Draft Guidance on DMCs

The FDA’s 2024 draft guidance emphasizes the critical role of independent DMCs in clinical trials, enhancing oversight, safety, and trial integrity.

Blog

DMC vs EAC: What’s the Difference?

Clinical research oversight relies on both DMCs for big-picture data review and EACs for detailed event assessments. Learn how each committee enhances trial safety.

Technology-enabled Reviews

Improve compliance and reduce administrative burden with the most integrated reviews solutions in the industry. All of our review services are supported by best-in-class technology platforms, which provide clients with real-time information on review timelines and deliverables.  Advarra’s reviews technologies integrate easily into a sponsor’s electronic trial master file (eTMF) platforms and site systems via API.

Improve compliance and reduce administrative burden with the most integrated reviews solutions in the industry.  

Advarra’s reviews technologies integrate easily into a sponsor’s electronic trial master file (eTMF) platforms and site systems via API. 

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Frequently Asked Questions

Explore our comprehensive FAQ page for detailed answers to questions about our IRB, IBC, DMC, and EAC services.

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